Effect of Massage After CABG on Pain, Sleep Quality and Serum Cortisol Level

NCT06529471 | Completed

• 2 other identifiers: 2023/11.26Kocaeli University
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The patient in the surgical treatment and care process has difficulty in meeting the need for sleep in the hospital, and accordingly, their habits, attitudes and behaviors regarding sleep and rest change. Studies have shown that hospitalized patients experience sleep deprivatio.The decrease in sleep duration and quality is an important component affecting recovery after surgery. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders. It has been reported that back massage reduces cortisol levels and blood pressure, slows heart rate and improves sleep quality (Pınar and Afşar 2015). This study was planned as a case-control study to evaluate the effect of massage therapy applied after open cardiovascular surgery on patients' pain, sleep quality and serum cortisol levels. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients after open heart surgery.

Conditions

Nursing Care; Massage; Pain; Cortisol

Keywords

massage; pain; nursing care; sleep; cortisol

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure

  Richard-Campbell Sleep Scale: RCSQ is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart from 0 to 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.

  Before the recruit pre-test (RCSQ- survey scale) will be applied. A post-test (RCSQ survey scale) will be administered again two days after the intervention.]

• Postoperative Pain Intensity (Numeric Rating Scale)

  Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates "no pain" and 10 indicates "worst possible pain." Pain will be measured at standardized time points for all participants. In the intervention group, pain will be assessed immediately before each massage session and 10 minutes after each session. In the control group, pain assessments will follow the same schedule corresponding to routine care time points. Higher scores indicate greater pain severity.

  Measured before each session and 10 minutes after each session, as well as on postoperative days 1 and 2.

Secondary Outcomes (1)

• Secondary Outcome Measure

  Before the recruit pre-test (serum cortisol-blood test) will be applied. A post-test (serum cortisol-blood test) will be administered two days after the intervention.]

Study Arms (2)

Group receiving massage

EXPERIMENTAL

In Postoperative 0, before the massage, the patient's sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (first test). In Postoperative 1, a back massage is applied three times (10:00-14:00-20:00). In Postoperative 2, sleep duration (with the Richard-Campbell Sleep Scale and smart watch) and cortisol level are measured (last test).

Other: Massage group

Standard care group

NO INTERVENTION

The patients in this group are given routine care practices of the clinic. Sleep and cortisol measurements are made in parallel with the experimental group.

Interventions

Massage group OTHER

The patient in the massage group will be visited by the practitioner 3 times at 10:00-14:00-20:00 on the first day after surgery and a back massage will be applied. The patient in the massage group will be placed in an orthopnea position during the application. The massage procedure lasts an average of 30 minutes and is applied to the cervical 3 and thoracic 12 vertebrae.

Group receiving massage

Eligibility Criteria

• Age: 40 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning for elective open heart surgery
• Being conscious
• Being extubated

You may not qualify if:

• Those who underwent minimally invasive cardiac surgery,
• Those who did not use an extracorporeal circulation machine
• Those who have an infectious disease such as varicella zoster on the back, or a structural disease such as scoliosis,
• Those who have another surgical procedure performed simultaneously on the back,
• Those who have no limb loss

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Türkiye, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied. While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Model Details: The study was conducted experimentally with a pre-test and post-test control group.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: September 1, 2023
• Primary Completion: September 4, 2023
• Study Completion: July 24, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)